FDA.reportPublic FDA data

Medex

Primary DI
50351688507288
Brand
Medex
Company
ICU MEDICAL, INC.
Model
MX452
Published
2016-12-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FPKTubing, fluid delivery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPKTubing, Fluid DeliveryGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50351688507288PackageGS150In Commercial Distribution
10351688507280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5035168850728850351688507288
1035168850728010351688507280

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration tubing extension setA collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
118380146
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709194219BivonaFU26EN60NGC168N2026-05-26
10887709194141BivonaFT26EN40NGE171N2026-05-22
10887709194158BivonaSU26EN45NGG172N2026-05-22
10887709194165BivonaFU26EN35NGF174N2026-05-22
10887709194172BivonaFT26EN40NGF176N2026-05-22
10887709194189BivonaSU26EN50NGF175N2026-05-22
10887709194196BivonaFT26EN70NSC177N2026-05-22
10887709188720BivonaAT26CS50NSA182N2026-03-24
10887709188737BivonaAT26CS40NSA180N2026-03-24
10887709188744BivonaAT26CS40NSA181N2026-03-24
10887709188751BivonaAT26CS50NSA183N2026-03-24
10887709188836BivonaSU26CN45NGF194N2026-03-24
10887709188843BivonaSU26CN50NGF193N2026-03-24
10887709188850BivonaFT26CN65NSC192N2026-03-24
10887709188874BivonaFT26CN40NGE196N2026-03-24
10887709188881BivonaFT26CN50NSA199N2026-03-24
10887709188904BivonaHF26CS80NSC198N2026-03-24
10887709188805BivonaSU26CN55NGF1902026-03-23
10887709188812BivonaSU26CN60NSC189N2026-03-23
10887709188829BivonaXT26CS70NSC191N2026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20884450807136High Pressure Tubing, Keep™Merit Medical Systems, Inc.FPK2025-11-25
20884450859586Pressure Monitor TubingMerit Medical Systems, Inc.FPK2025-09-05
10884450815400High Pressure TubingMerit Medical Systems, Inc.FPK2025-07-23
10884450569235Merit Medical®Merit Medical Systems, Inc.FPK2025-06-19
10884450859619Pressure Monitor TubingMerit Medical Systems, Inc.FPK2025-05-13
10884450859657Pressure Monitor TubingMerit Medical Systems, Inc.FPK2025-05-13
10884450859671Pressure Monitor TubingMerit Medical Systems, Inc.FPK2025-05-13
20884450569218Merit Medical®Merit Medical Systems, Inc.FPK2025-04-21
20884450833340Merit Medical®Merit Medical Systems, Inc.FPK2025-04-21
20884450859609Pressure Monitor TubingMerit Medical Systems, Inc.FPK2025-04-21
10884450859565High Pressure TubingMerit Medical Systems, Inc.FPK2025-03-15
20884450859593Pressure Monitor TubingMerit Medical Systems, Inc.FPK2025-02-26
10884450859893High Pressure TubingMerit Medical Systems, Inc.FPK2025-01-28
20884450859883High Pressure TubingMerit Medical Systems, Inc.FPK2025-01-22
20884450628304Merit Medical®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.FPK2024-12-07
20884450821262High Pressure Tubing, Keep™Merit Medical Systems, Inc.FPK2024-11-01
20884450569379Pressure Monitor TubingMerit Medical Systems, Inc.FPK2024-10-18
50192253003336MonojectCardinal Health 200, LLCFPK2024-08-21
50192253003343MonojectCardinal Health 200, LLCFPK2024-08-21
20192253003359MonojectCardinal Health 200, LLCFPK2024-08-21
20884450807112High Pressure Tubing, Keep™Merit Medical Systems, Inc.FPK2024-07-20
10884450807108High Pressure TubingMerit Medical Systems, Inc.FPK2024-07-18
10884450821258High Pressure TubingMerit Medical Systems, Inc.FPK2024-07-12
20884450821224High Pressure TubingMerit Medical Systems, Inc.FPK2024-07-02
10884450821234High Pressure TubingMerit Medical Systems, Inc.FPK2024-06-26
20884450815322High Pressure TubingMerit Medical Systems, Inc.FPK2024-06-12
40616258024552Swabbable Valve Transfer SetBayer Medical Care Inc.FPK2024-05-06
40616258024569MEDRAD® Twist & Go Disposable Syringe 150mL with Quick Fill TubeBayer Medical Care Inc.FPK2024-05-06
40616258024828MEDRAD® Twist & Go Disposable Syringe 150mL with Quick Fill TubeBayer Medical Care Inc.FPK2024-05-06
10884450807122High Pressure TubingMerit Medical Systems, Inc.FPK2024-03-12